Introduction to Phase II Track with Joel Owen

Authors: Owen JS
Conference: SLP MIDD+
Keywords: MIDD (model-informed drug development), modeling and simulation, Pharmacometric, Phase II, predictive quantitative models, SLP MIDD+ Virtual Conference, SLP2021MIDD
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Joel Owen, Vice President of Pharmacometric Services, gives a brief introduction to the application of Modeling & Simulation in Phase 2 – questions to be addressed, speakers, and presentations.​

  • Can we develop predictive quantitative models for safety and efficacy endpoints?​
  • Can we confirm mechanisms of action; clinical utility and validation potential of biomarkers?​
  • What is the best dose and study design for the subsequent Phase 3 trials?

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Presented at SLP MIDD+ Virtual Conference March 3-4, 2021